Seoul National University Hospital Clinical Trials Center
Seoul, 110-744, South Korea
NCT Number: NCT01503658
This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;
1. Primary
* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel * To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel 2. Secondary
* To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel * To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel * To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel
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Notify Me20 year–45 year
Male
Interventional
Phase 4
Seoul, 110-744, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clopidogrel 75 mg, Aspirin 100 mg
Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h postdose on Day 1, Day 15 and Day 29
Plasma concentration of clopidogrel and active metabolite of clopidogrel
Time frame: Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29
Relative inhibition of platelet aggregation by aggregometer or VerifyNow
Time frame: predose on Day 1, Day 8, Day 15, Day 22 and Day 29
mRNA of PON1 and CYP2C19, CYP3A5, MDR1 microRNA endogenous metabolite
Seoul National University Hospital
Other
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers
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